Bacillus anthracis, the pathogen for Anthrax, has been identified as a top priority biowarfare target by the Department of Defense, and as a Category A agent by Centers for Disease Control. It is estimated that three days after the release of 50 kgs of anthrax spores along a 2 km line upwind of a city of 500,000 population, 125,000 infections would occur, leading to 95,000 deaths. The economic impact of such a scenario is estimated to be $26.2 billion per 100,000 exposed to Anthrax. A major unmet need is effective therapy for treatment of anthrax after exposure to aerosolized spores. The studies proposed herein will demonstrate that administration of Anthim with an IM formulation will be effective in treatment of post-exposure anthrax alone or in conjunction with antibiotics. Long term objectives. Elusys's long-term objective is to produce a liquid or lyophilized formulation of our drug candidate Anthim that is an effective product for the treatment of Anthrax infection and has a favorable shelf life and convenient IM route of administration for biowarfare emergency situations. Elusys is actively developing the drug candidate Anthim, an ultra high affinity monoclonal antibody (MAb) to the protective antigen component of the anthrax toxin. This antibody has been tested in animal models and shown to be efficacious in protecting animal subjects from death. Specific Aims. We hypothesize that the formulation studies proposed here will enable the production of an Anthrax therapeutic that is stable, has a long shelf-life and can be given rapidly via IM administration. Specific Aim #1: Produce antibody to support comparability testing, formulation development and in vivo animal testing. Milestone #1: Production of 40 grams of antibody. Specific Aim #2: Develop a stable formulation of Anthim for commercialization. Milestone #2: Development of process for production of a stable formulation of Anthim. Specific Aim #3: Show efficacy through vivo animal testing using a relevant animal model. Milestone #3: Comparable results of reformulated Anthim in comparison with the reference standard. Research & Development Methods. A Master Cell Bank (MCB) for the production cell line is currently being developed and tested. Antibody will be produced from this cell line for formulation studies. Formulation studies will be conducted to develop a stable formulation, containing the maximum concentration of Anthim determined in the pre-formulation study and a functional lyophilization cycle for making small batches. Following formulation development, a comparability program and both vivo and in vitro studies will be conducted to compare the new formulation to a previous reference standard. [unreadable] [unreadable] [unreadable]